Messages in brief
SPC harmonisation of veterinary medicinal products
messages in brief
|
09/05/2022
With the entry into force of the Regulation (EU) 2019/6 a new procedure, the SPC harmonisation procedure, was created as per Section 4 of this Regulation.
SPC harmonisation of veterinary medicinal products
Read more
Clinical testing of veterinary medicinal products
messages in brief
|
09/05/2022
The new EU Veterinary Medicinal Products Regulation, which entered into force on 27/01/2019, is applicable from 28/01/2022. According to Article 9 of this Regulation, applications for approval of clinical trials of veterinary medicinal products shall be submitted to the competent authority of the Member State in which the clinical trial is to be conducted.
Clinical testing of veterinary medicinal products
Read more
EU Recommendations for the Seasonal Influenza Vaccine Composition for the Season 2022/2023
messages in brief
|
02/05/2022
The EMA adopted the new recommendations for the composition of seasonal influenza vaccines for the season 2022/2023 (published 29 March 2022).
EU Recommendations for the Seasonal Influenza Vaccine Composition for the Season 2022/2023
Read more
Clinical studies and the war in Ukraine
messages in brief
|
05/04/2022
Clinical studies and the war in Ukraine - Information for Consumers.
Clinical studies and the war in Ukraine
Read more
Clinical studies and the war in Ukraine
messages in brief
|
05/04/2022
Clinical studies and the war in Ukraine - Information for Healthcare Professionals.
Clinical studies and the war in Ukraine
Read more
Current issue of “RMS NEWS”
messages in brief
|
31/03/2022
This issue of RMS NEWS again contains current and relevant news for our applicants for marketing authorisations with Austria as RMS.
Current issue of “RMS NEWS”
Read more
Online-Form: Side effects veterinary drugs
messages in brief
|
18/02/2022
Reporting suspected adverse reactions to veterinary drugs is possible using an online form.
Online-Form: Side effects veterinary drugs
Read more
Amendments to the AMG (Austrian Medicines Act, Arzneimittelgesetz) concerning notifications of discontinuation of placing on the market
messages in brief
|
14/02/2022
With the AMG amendment of 14.02.2022, § 21(2) was changed to the effect that the BASG must now be notified four months (instead of the previous two months) in advance of a temporary or permanent discontinuation of the marketing of medicinal products.
Amendments to the AMG (Austrian Medicines Act, Arzneimittelgesetz) concerning notifications of discontinuation of placing on the market
Read more
BASG information concerning the new Veterinary Medicinal Products Regulation
messages in brief
|
07/02/2022
The new Veterinary Medicinal Products Regulation is to be applied as of 28.01.2022.
BASG information concerning the new Veterinary Medicinal Products Regulation
Read more
Current issue of “RMS NEWS”
messages in brief
|
31/01/2022
This issue of RMS NEWS again contains current and relevant news for our applicants for marketing authorisations with Austria as RMS.
Current issue of “RMS NEWS”
Read more